FDA — authorised 28 December 2022
- Application: BLA761238
- Marketing authorisation holder: TG THERAPEUTICS, INC
- Local brand name: BRIUMVI
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
🇺🇸 BRIUMVI in United States
FDA authorised BRIUMVI on 28 December 2022
Marketing authorisations
FDA
- Status: approved
BRIUMVI in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Neuroscience approved in United States
Frequently asked questions
Is BRIUMVI approved in United States?
Yes. FDA authorised it on 28 December 2022; FDA has authorised it.
Who is the marketing authorisation holder for BRIUMVI in United States?
TG THERAPEUTICS, INC holds the US marketing authorisation.